MOVANTIK Film-coated tablet Ref.[10882] Active ingredients: Naloxegol

2.1 Administration Instructions

• Discontinue all maintenance laxative therapy prior to initiation of MOVANTIK. Laxative(s) can be used as needed if there is a suboptimal response to MOVANTIK after three days.
• Alteration in analgesic dosing regimen prior to initiating MOVANTIK is not required.
• Patients receiving opioids for less than 4 weeks may be less responsive to MOVANTIK [see Clinical Studies (14)].
• Take MOVANTIK on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
• For patients who are unable to swallow the MOVANTIK tablet whole, the tablet can be crushed to a powder, mixed with 4 ounces (120 mL) of water, and drunk immediately. The glass should be refilled with 4 ounces (120 mL) of water, stirred and the contents drunk.
• MOVANTIK can also be administered via a nasogastric (NG) tube, as follows:
  • Flush the NG tube with 1 ounce (30 mL) of water using a 60 mL syringe.
  • Crush the tablet to a powder in a container and mix with approximately 2 ounces (60 mL) of water.
  • Draw up the mixture using the 60 mL syringe and administer the syringe contents through the NG tube.
  • Add approximately 2 ounces (60 mL) of water to the same container used to prepare the dose of MOVANTIK.
  • Draw up the water using the same 60 mL syringe and use all the water to flush the NG tube and any remaining medicine from the NG tube into the stomach.
• Avoid consumption of grapefruit or grapefruit juice during treatment with MOVANTIK.
• Discontinue MOVANTIK if treatment with the opioid pain medication is also discontinued.

2.2 Adult Dosage

The recommended MOVANTIK dosage is 25 mg once daily in the morning. If patients are not able to tolerate MOVANTIK, reduce the dosage to 12.5 mg once daily [see Clinical Pharmacology (12.2)].

2.3 Dosage in Adult Patients with Renal Impairment

The starting dosage for patients with creatinine clearance (CLcr) <60 mL/min (i.e., patients with moderate, severe, or end-stage renal impairment) is 12.5 mg once daily. If this dosage is well tolerated but OIC symptoms continue, the dosage may be increased to 25 mg once daily taking into consideration the potential for markedly increased exposures in some patients with renal impairment and the increased risk of adverse reactions with higher exposures [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.4 Dosage Recommendations due to Drug Interactions

Avoid concomitant use of MOVANTIK with moderate CYP3A4 inhibitor drugs (e.g., diltiazem, erythromycin, verapamil). If concurrent use is unavoidable, reduce the MOVANTIK dosage to 12.5 mg once daily and monitor for adverse reactions [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

In a clinical study of patients with OIC a daily dose of 50 mg (twice the recommended dosage), administered over 4 weeks, was associated with an increased incidence of GI adverse reactions, such as abdominal pain, diarrhea, and nausea. These adverse reactions frequently occurred within 1-2 days after dosing.

No antidote is known for naloxegol. Dialysis was noted to be ineffective as a means of elimination in a clinical study in patients with renal failure.

If a patient on opioid therapy receives an overdose of naloxegol, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms such as chills, rhinorrhea, diaphoresis, or reversal of central analgesic effect. Base treatment on the degree of opioid withdrawal symptoms, including changes in blood pressure and heart rate, and on the need for analgesia.

Store MOVANTIK at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].